Events

Retiro De Equipo (Recall) de Device Recall Verify SixCess Indicator Strips

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Steris Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    59713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3045-2011
  • Fecha de inicio del evento
    2011-03-16
  • Fecha de publicación del evento
    2011-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103395
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Indicator, physical/chemical sterilization process - Product Code JOJ
  • Causa
    During an inspection the firm was notified that language contained in labeling and promotional literature directs customers that the products can be used to replace biological indicators and/or release loads containing implants.
  • Acción
    STERIS sent a Customer Notification letter dated March 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review and follow the Challenge Packs' revised instructions for use enclosed as Attachment A (270-4) and Attachment B (275F 3). For any questions regarding this recall customers were instructed to contact their STERIS Account Manager or call 440-392-7421.

Device

Device Recall Verify SixCess Indicator Strips
  • Modelo / Serial
    Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038,
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
  • Descripción del producto
    Verify¿ SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. || Verify¿ SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250¿F 30 minute Gravity Cycle).
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Dirección del fabricante
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    USFDA